0.8% SELECTOGEN; 0.8% SURGISCREEN; 0.8% AFFIRMAGEN; 0.8% RESOLVE PANELS A, B, C; 0.8% POOLING SCREENING CELLS

STN: 103778
Proper Name: Reagent Red Blood Cells
Tradename: 0.8% SELECTOGEN; 0.8% SURGISCREEN; 0.8% AFFIRMAGEN; 0.8% RESOLVE PANELS A, B, C; 0.8% POOLING SCREENING CELLS
Manufacturer: Ortho-Clinical Diagnostics, Inc.
Indication:

• A qualitative test for the Identification of unexpected blood group antibodies using the ID-Micro Typing System Gel Test methods.
• For in vitro diagnostic use

Product Information:

• Package Insert - ORTHO 0.8% Pooled Screening Cells
• Package Insert - Resolve Panel A
• Package Insert - Resolve Panel B
• Package Insert - Resolve Panel C
• Package Insert - Affirmagen
• Package Insert - Selectogen
• Package Insert - Surgiscreen

Supporting Documents

• February 10, 2026 Approval Letter - 0.8% RESOLVE Panels, A, B, and C
• March 10, 2021 Approval Letter - 0.8% SELECTOGEN; 0.8% SURGISCREEN; 0.8% AFFIRMAGEN; 0.8% RESOLVE PANELS A, B, C; 0.8% POOLING SCREENING CELLS